Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer

NCT ID: NCT05545592

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-06-01

Brief Summary

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This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.

Detailed Description

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According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).

Conditions

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FET

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low oestrogen

The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles

Group Type EXPERIMENTAL

Low oestrogen dosage

Intervention Type OTHER

From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.

Regular oestrogen

The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low oestrogen dosage

From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Female;
2. Aged between 20 and 40 years old;
3. Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
4. Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
5. The total number of transfer cycles was \< 3;
6. Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria

1. Patients with chromosomal abnormalities;
2. Contraindications to hormone replacement therapy;
3. Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
4. Participating in other clinical studies.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing University

OTHER

Sponsor Role lead

Responsible Party

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Li-jun Ding

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Xing

Role: CONTACT

+862583107188

Chenyang Huang

Role: CONTACT

+862583107188

Facility Contacts

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Jun Xing

Role: primary

+86 25 8310 7188

Other Identifiers

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SZ-HRT-2022

Identifier Type: -

Identifier Source: org_study_id

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